Safety Study of Two Repeat Doses of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

This study's objective is to evaluate if RT001 is safe and well-tolerated following two (2) sequential applications.

Condition or disease

Intervention/treatment

Phase

Lateral Canthal LinesCrow's FeetFacial Wrinkles

Drug: RT001

Phase 2

Detailed Description:

Revance is conducting this Phase 2 clinical study to establish the safety of two (2) sequential doses of RT001 Topical Gel at Baseline (Day 0) and Week 4 for the treatment of moderate to severe LCLs at rest.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years to 65 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Written informed consent including authorization to release health information

Female or male, 18 to 65 years of age and in good general health

Willing and able to follow study instructions and likely to complete all study requirements

Moderate to severe lateral canthal lines (crow's feet wrinkles)

Exclusion Criteria:

Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis

Muscle weakness or paralysis, particularly in the area receiving study treatment

Active disease or irritation at the treatment areas including the eye and the skin

Pregnant, nursing, or planning a pregnancy during the study; or is a woman of child bearing potential (WOCBP) but is not willing to use an effective method of birth control